Belviq® (lorcaserin hydrochloride) Diet Pills.

News: Belviq® is the official trademarked name for Lorcaserin, it has been given an FDA approval for the treatment of obesity June 27th, 2012.

Buy Lorcaserin / Belviq®

Belviq® is the new trademarked name for what is currently a trial anti obesity medication called Lorcaserin hydrochloride. This drug was discovered and developed by the company Arena Pharmaceuticals located in San Diego California. Arena is also known by their stock symbol ARNA which trades on the Nasdaq Stock Exchange.

More Information on Lorcaserin / Belviq®

          Belviq® (Lorcaserin) behaves as an appetite suppressant which helps patients lose weight by essentially causing them to feel less hunger sensations. As a result, less food is ingested which means the body is taking in less calories and the result is a reduction in weight. It accomplishes this by altering various 5-HT2C serotonin receptors found within the hypothalamus which is responsible for ones appetite and their metabolism. It is what is called a selective serotonin 2C receptor agonist. It works similarly to what is now a banned drug fenfluramine which was the drug responsible for various heart problems such as cardiac fibrosis and cardiac valvulopathy in the dreaded concoction Fen-Phen. However since Belviq® is far more selective than fenfluramine, none of the destructive heart issues have been noticed in clinical tests. This is very good news for its maker and the general obese public if indeed the FDA confirms these findings, however some people think that medication is the wrong approach to fighting obesity related health issues.
          For a drug to be considered effective in fighting obesity, it must pass certain FDA guidelines as well as prove to be relatively safe. Arena Pharmaceuticals has researched Belviq® for several years and is convinced that both its effectiveness as well as its safety is ready for public use. As a result the company presented the drug to the FDA with a New Drug Application on December 22nd of 2009. The FDA will have an advisory panel review the application and give its vote on whether or not they would recommend the FDA to approve it or not on the proposed day of October 22nd, 2010. This will be the date that the ultimate decision is made on its approval or lack there of. In most cases the FDA tends to take the advice of their advisory panel.
           Earlier Medical testing (Phase 2) involving Belviq® showed that patients taking the drug lost more weight than those who took the placebo. The testing was done over a 12 week period and involved 3 different amounts 10mg, 15mg and 20mg daily. After the testing was completed, the patients taking Belviq® lost on average 4lbs with the 10mg dose, 5.7lbs with the 15mg dose and almost 8 lbs taking 20mg. Compared to the placebo group the findings where substantial as the placebo group averaged a mere 0.7lb decrease.
          Phase 3 testing (more extensive, 52 week test, involving over 3000 obese patients taking 10mg twice daily) also backed up the earlier results with an average patient weight loss of 5.8%(12.7lbs) compared to the placebo groups results of 2.2%(4.7lbs) The study also showed that 22% of lorcaserin taking patients lost 10% or greater bodyweight measured to the 7.7% of the placebo group, also notable was that 47.5% of Belviq® patients lost at least 5% of their weight where as the placebo percent was 20.3%. Belviq® has also been linked to drops in cholesterol levels and other cardiovascular benefits. All in all, Lorcaserin has been shown to meet the FDA requirements for a medication to be considered an obesity fighting drug which states that at least a third of the trial patients lose at least 5% of their bodyweight over the placebo or that at least two times the patients over the placebo group must have experienced a 5% weight loss.
          Side effects reported in clinical testing of Belviq® have looked mild and fairly tolerable. The most commonly reported side effect was headaches with approximately 18% of users experiencing them, however it must be pointed out that 11% of the placebo group actually experienced headaches and this was the only side effect that was above a 5% placebo difference. Other most common side effects reported were dry mouth, fatigue, nausea, vomiting, and dizziness. In most people any side effects usually went away after their body got used to it. Another interesting fact was that the discontinue rates for testing was the same (7%) for actual Belviq® users and the placebo group. This is the lowest placebo adjusted discontinue rate for an obesity drug ever. Here are some other current or past obesity medication discontinue rates:

Qnexa® (phentermine IR/topiramate CR) 18% - Placebo 9%
Meridia® (sibutramine) 9% - Placebo 9%
Contrave® (bupropion SR/naltrexone IR) 26% - Placebo 13%
Alli® or Xenical® (Orlistat) 7% - Placebo 4%
Acomplia® (Rimonabant) 15% - Placebo 7%

Testing also has shown that there is a very low chance of abuse/addiction with Belviq patients trying to feel elated (high) from it.

July 1st, 2010
Arena Pharmaceuticals have signed an agreement with Eisai Co of Japan to sell its obesity drug Lorcaserin in the United States pending approval. The agreement affirms that Arena Pharmaceuticals will manufacture the drug at its facility in Switzerland then proceed in selling the medication to Eisai Co who will have the complete marketing rights. The agreement states that Arena Pharmaceuticals will be given 50 million dollars upfront with a possible additional 90 million dollars if the FDA approves it. If all goes as planned, it is their hopes to have Lorcaserin available 12 weeks after FDA approval.

July 14th, 2010
A clinical study featuring Lorcaserin shows that it is useful for weight loss and does not contain heart related side effects and overall little health risk. The research study also confirmed that lorcaserin caused a higher number of people to lose 5% or more of their weight over a 52 week period than the placebo group. In fact it resulted in being more than double the rate of placebo group. The results are in Thursday's New England Journal of Medicine.

Sept 14th, 2010
Today the FDA released a preliminary review of Lorcaserin. It stated it was effective but by a "slim margin." They mentioned that although somewhat effective it did manage to fail one of the benchmarks for weight loss. The FDA also questions various safety issue about it such as heart value problems and psychiatric issues. Although this paints a bleak picture thus far for Lorcaserin, it should be noted that often FDA reviews released before advisory panel meetings can be quit critical. Thursday's meeting will give a better indication of Lorcaserin's future when an advisory panel votes on whether the FDA should approve it or not.

Sept 16th, 2010
The FDA's panel, an outside group of medical experts, voted 9-5 against recommendation for Lorcaserin. Some of the more prevalent concerns where that it could possibly be linked to cancerous tumors as noted in lab rats. The lab rats however where reported to have been on extremely excessive dosages. The FDA usually follows the advise of their panel's vote but is not required to do so. October 22nd 2010 is the expected date for the FDA to give it's decision on whether it will approve Lorcaserin for weight loss or not.

October 23rd, 2010
The FDA issued a complete response letter to Arena today stating that Lorcaserin was rejected in its present form. There where clinical and non clinical reasons for their decision and the FDA requested additional data. Jack Lief, Arena's president and CEO said "This is an important step for us toward the FDA's approval of lorcaserin," "While the complete response letter provides us with recommendations from the agency, we intend to meet with the FDA to obtain further clarity on the approval path and timeline. We will work with the agency to address the issues with our NDA as quickly as possible."

November 9th, 2010
Information from the Phase 3 BLOOM-DM trial has been shown to help people suffering from diabetes to lose weight. The study included 600 people and patients achieved a 0.9% reduction in the HbA1c blood sugar benchmark. The placebo group had a 0.4% reduction. What also needs to be addressed is that, although apparently minor, valvulopathy seems to have been detected in 2.9% of patients taking Lorcaserin compared to 0.5% of patients on the placebo at week 52 of the study. Arena plans to meet and discuss these findings with the FDA before the end of 2010. Jack Lief also is quit confident of trying to proceed with gaining approval of Lorcaserin in Europe.

*** Note, the Contrave Diet Drug received a 13-7 vote in favor of approving it as a weight loss medication on December 7th. This may or may not influence Lorcaserin's ultimate fate. (It was later reported that Contrave failed FDA approval)

December 22nd, 2010
Arena has announced an end-of-review meeting with the FDA regarding Lorcaserin. Jack Lief Arena's CEO stated "Based on guidance we have received from the agency, we are executing several activities and expect to resubmit the lorcaserin NDA by the end of 2011." Clinical safety testing will continue to address the rat tumors that where found at extremely high doses. It is believed that they will be able to show that this is fairly irrelevant to humans.

August 2nd, 2011
Arena Pharmaceuticals announced that its study of lorcaserin concentrations in human cerebrospinal fluid in order to determine levels of accumulation of lorcaserin in the brain has shown favorable results. It was determined that lab rats at the rate of 10mg/kg/day had upwards of 24 times the exposure to their brain than what was measured in their blood. Humans as 10mg dosed twice daily (BID) had approximately 1.7 times.

November 9th, 2011
Today Jack Lief, the President and CEO of Arena Pharmaceuticals, said in the 3rd Quarter Financial Results some encouraging words regarding the progress of Lorcaserin with regards to having it approved. These are his words: "We are focused on submitting our response to the FDA for the lorcaserin complete response letter around year-end (2011) and filing the lorcaserin marketing authorization application with the European Medicines Agency in the first half of next year (2012)"

January 3rd, 2012
Today Arena and its partner Eisai Inc revealed that they have completed a formal response letter to the FDA. It is believed that this letter will ease the concern for any correlation between Lorcaserin and cancer. Earlier testing showed that there could be reason for concern with this in test rats. Arena Pharmaceuticals is confident that they have addressed these issues and that Lorcaserin will be approved soon as a medication to fight obesity. The FDA will ultimately have to decide on this provided information and determine the outcome. The FDA's next step is to acknowledge this letter and provide a future date for a panel advisory review and an official FDA review.

January 10th, 2012
The FDA has accepted the resubmission of the New Drug Application (NDA) and has assigned a tentative Target Action date of June 27th 2012 for the discussion on whether Lorcaserin should be approved or not.

February 1st, 2012
The FDA and told Arena Pharmaceutical / Eisai Inc that the NDA(New Drug Application) will be discussed sometime in the 2nd quarter of 2012. No specific date has been set as of yet.

March 26th, 2012
The FDA has tentatively set an advisory panel board meeting May 10th, 2012 to review the drug Lorcaserin for the treatment of obesity. This Endocrinologic and Metabolic Drugs Advisory Committee will discuss the New Drug Application (NDA) and give their opinion on whether they believe it should be approved. Today also marks the day that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Lorcaserin to treat obesity within the EU.

May 10th, 2012
A group of medical advisors to the FDA have voted in favor of accepting Lorcaserin for the treatment of obesity. The vote was 18-4 in favor, with one not submitting a vote. The FDA most often uses their panels recommendation when making a decision for a new drug acceptance but is not obligated to do so. The FDA will make the final decision June 27th 2012. More Info on Lorcaserin